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510(k) Data Aggregation
(61 days)
The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site.
The SEAL ONE® may be used on the right or left wrist. The device placement time should be set on the time indicator, which should subsequently be locked. Wrist strap is secured by a strap which is clipped. The wrist strap can be twisted in to shorten it. Compression is applied by turning the compression knob clockwise. Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise. It is possible to write on the wrist strap with ballpoint pen or indelible felt pen, to indicate the times at which the device was checked and steps during decompression. The dedicated positions for this are shown by the following symbols at the ends of the wrist strap.
The PEROUSE MEDICAL SEAL ONE® Radial Compression Device is intended for use in coronary angiography and angioplasty procedures to compress the puncture site when a radial approach is used. The device's performance was evaluated through various preclinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met biocompatibility requirements (demonstrating safety in terms of biological interactions). |
| Safety and Functionality - Bench Testing | The device successfully underwent testing during design qualification, in accordance with an internal protocol. This included evaluation of: |
| - Aspect | The physical appearance of the device met specified requirements. |
| - Preparation of the system | The device could be prepared for use as intended. |
| - Positioning of the system on the wrist | The device could be correctly positioned on the wrist. |
| - Compression / decompression functionality | The compression and decompression mechanisms operated as designed (i.e., turning the knob clockwise for compression, and simultaneously pressing the safety button and turning anticlockwise for decompression). |
| - Device positioned and functioning | The device remained correctly positioned and functioned effectively during use. |
| - Removal of the device at the end of process | The device could be safely and easily removed after the procedure. |
| - Used on a patient in the coronary and angiography environment | The device demonstrated functionality and suitability for use in a clinical (coronary and angiography) environment, though details of this "use" are not elaborated as a formal patient study. |
Study Details:
The provided summary describes a submission for 510(k) clearance, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (TR BAND™) and thorough preclinical testing rather than a clinical trial with a large test set of patient data.
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2. Sample size used for the test set and the data provenance:
The document does not specify a patient-based test set size or data provenance for evaluating the device's performance through a clinical study. The performance data listed (biocompatibility, safety and functionality bench testing, and "used on a patient in the coronary and angiography environment") appear to be from preclinical and possibly limited clinical observations (without formal study design details). The reference to "used on a patient" is vague and does not indicate a structured sample size. -
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given the nature of the tests (bench testing), external expert adjudication of ground truth in the traditional sense would not be applicable in the same way it would be for diagnostic AI. The "ground truth" for bench tests is adherence to design specifications and functional requirements. -
4. Adjudication method for the test set:
An adjudication method like 2+1 or 3+1 is not applicable as there was no formal clinical study with a test set requiring independent assessment of outcomes. The evaluation involved successful completion of predefined internal protocols for bench testing and potentially observational use. -
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was performed or is relevant to this device. This device is a radial compression device, not an AI-assisted diagnostic tool. -
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the SEAL ONE® is a physical medical device, not a software algorithm. -
7. The type of ground truth used:
The "ground truth" for this device's performance was based on engineering specifications, functional requirements, and internal test protocols. For biocompatibility, it would be adherence to relevant ISO standards. For functionality, it was the successful operation of the device as designed during bench testing. -
8. The sample size for the training set:
This question is not applicable as there is no mention or implication of a training set, as the device is a physical medical device, not a machine learning algorithm. -
9. How the ground truth for the training set was established:
This question is not applicable for the reasons stated above.
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